§ 520.1780 Pimobendan tablets.
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Verbatim text below is from the Electronic Code of Federal Regulations (eCFR), a public-domain U.S. government work. Always verify the current version with the eCFR before relying on it for any legal matter.
Full Text
Specifications.(a) Each chewable tablet contains 1.25, 2.5, 5, or 10 milligrams (mg) pimobendan.
Sponsors.(b) See Nos. 000010 and 069043 in § 510.600(c) of this chapter.
Conditions of use in dogsAmount.(c) —(1) Administer orally at a total daily dose of 0.23 mg per pound (0.5 mg per kilogram) body weight, using a suitable combination of whole or half tablets. The total daily dose should be divided into two portions administered approximately 12 hours apart.
Indications for use.e.g.,(2) For the delay of onset of congestive heart failure in dogs with Stage B2 preclinical myxomatous mitral valve disease. Stage B2 preclinical myxomatous mitral valve disease (MMVD) refers to dogs with asymptomatic MMVD that have a moderate or loud mitral murmur due to mitral regurgitation and cardiomegaly. For the management of the signs of mild, moderate, or severe congestive heart failure in dogs due to clinical MMVD or dilated cardiomyopathy (DCM); for use with concurrent therapy for congestive heart failure ( furosemide, etc.,) as appropriate on a case-by-case basis.
Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[72 FR 27733, May 17, 2007, as amended at 79 FR 18158, Apr. 1, 2014; 87 FR 10968, Feb. 28, 2022; 89 FR 42357, May 15, 2024; 89 FR 85426, Oct. 28, 2024; 91 FR 20341, Apr. 16, 2026]
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